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一种用于测定人血浆样本中比索洛尔的新型液相色谱-串联质谱法。

A new liquid chromatography-tandem mass spectrometry method for determination of bisoprolol in human plasma samples.

作者信息

Peste Gabriela, Bibire Nela, Apostu Mihai, Vlase Aurel, Oniscu Corneliu

机构信息

Center for Drug Evaluation, Antibiotice S.A., Iasi, Romania.

出版信息

J Biomed Biotechnol. 2009;2009:736327. doi: 10.1155/2009/736327. Epub 2009 Aug 19.

Abstract

Liquid chromatography (LC) coupled with mass spectrometry (MS) detection is one of the most powerful analytical tools for organic compound analysis. The advantages of using LC/MS methods over HPLC methods include: selectivity, chromatographic integrity, peak assignment, structural information, and rapid method development. In this paper, a new liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for the determination of bisoprolol in human plasma samples, using metoprolol as internal standard and liquid-liquid extraction procedure. The assay has proven to be sensitive, specific and reproducible, suitable to determine the bisoprolol concentration, following a single oral administration of a 10 mg bisoprolol tablet in 22 healthy volunteers, in the bioequivalence study of Bisoprolol 10 mg coated tablets, produced by Antibiotice S.A. versus Concor 10 mg, produced by Merck.

摘要

液相色谱(LC)与质谱(MS)检测联用是有机化合物分析中最强大的分析工具之一。使用LC/MS方法相对于HPLC方法的优势包括:选择性、色谱完整性、峰归属、结构信息以及快速的方法开发。本文建立并验证了一种新的液相色谱-串联质谱(LC-MS/MS)方法,用于测定人血浆样品中的比索洛尔,以内标美托洛尔和液-液萃取程序进行。在由Antibiotice S.A.生产的比索洛尔10 mg包衣片与由默克公司生产的康可10 mg的生物等效性研究中,该测定方法已被证明灵敏、特异且可重现,适用于在22名健康志愿者单次口服10 mg比索洛尔片后测定比索洛尔浓度。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f1bc/2729129/7d03ff7234d0/JBB2009-736327.001.jpg

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